![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Grants Genentech Priority Review for Atezolizumab
FDA Grants Genentech Priority Review for Atezolizumab
Roche’s Genentech unit has won FDA priority review of its atezolizumab BLA to treat a type of bladder cancer.
The company is studying the candidate in locally advanced or metastatic urothelial carcinoma in patients whose disease had progressed during or following platinum-based chemotherapy. An FDA decision is expected by Sept. 12.
Atezolizumab received breakthrough therapy designation in May 2014. It also is being assessed in other cancers.
Upcoming Events
-
21Oct